Japan 2023: Medical Device Regulatory Update

With a market size of about $30 billion, Japan is the third largest medical device market in the world, however, it is not an easy market to enter. Learn strategies for determining the best regulatory path for your product and investigating market access in this 90-minute live webcast. The presentation will help you better determine the best regulatory registration and reimbursement strategies, required steps, and documentation needed to enter the Japanese medical device market. The program will also cover:

• Japanese clinical trials
• DMAH/MAH third party registration
• SaMD
• Sakigate
• The importance of Japanese KOLs
• A case study on reimbursement

REGISTRATION FEES & DEADLINES

11 November 2022 – 23 December 2022: Early Bird $150 Member | $175 Nonmember
24 December 2022 – 24 January 2023: Regular $175 member | $200 Nonmember

Learning Objectives

This virtual program will answer questions including:

• How do you classify your device in Japan?
• When and how can you consult with the PMDA?
• What are the registration routes?
• What documents are required for product registration, Foreign Manufacturer Registration (FMR), and Quality Management Systems (QMS)
• How does Japan evaluate SaMD?
• How is reimbursement determined?
• What strategies can be employed to increase reimbursement?
• What factors should be considered for Japan entry?

Who Should Attend?

Regulatory Affairs Professionals

Speakers:

Ames Gross
President and Founder, Pacific Bridge Medical

Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory issues and business development in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, Medical Device and Diagnostic Industry (MD&DI) magazine named Mr. Gross one of the top 100 executives in the medical business. Mr. Gross is a frequent contributor of articles on Asian medical issues for RAPS, Clinica (England), MD&DI (Los Angeles), and other medically-oriented journals. He has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.